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France faces orthopaedic implant shortage risk in 2025

France faces an orthopaedic implant crisis as 2025 budget cuts enforce a 25% annual reimbursement reduction, risking shortages of vital prostheses, reports Bernard Banga.

Prosthetic limbs, such as the one shown, are among the orthopaedic implants at risk of shortages in France due to significant budget cuts in reimbursement rates starting in 2025. Credit: chandchand / Shutterstock

The French government is this year set to implement drastic changes to the pricing agreements for orthopaedic implantable medical devices. The Economic Committee for Health Products (CEPS) has signalled a 25% reduction in the annual reimbursement rates for orthopaedic prostheses over the next three years, with an initial cut of 5.7% this year. The government’s goal is to reduce sales prices by 11% by 2027.

“This significant price reduction puts the availability of these prostheses in jeopardy, with a real risk of shortages and the potential disappearance of implants from the French market, which would have worrying economic and public health consequences,” warned Patrice Mertl, Head of the Orthopaedic and Trauma Department at Amiens University Hospital and President of the 2024 Congress of the French Society of Orthopaedic and Trauma Surgery (Sofcot), speaking during a special session at the National Academy of Surgery.

A Fragile Sector and Low Intervention Rates in Europe

The sector has been navigating a challenging time since 2020. The Covid-19 pandemic disrupted orthopaedic surgery, causing massive delays in non-urgent procedures, with 40 to 50% of operations postponed. The war between Russia and Ukraine further disrupted the supply of titanium, a critical material in orthopaedics, leading to a 20% increase in metal prices. Finally, implementation of the European Medical Devices Regulation (MDR) has driven up the cost of orthopaedic implants by as much as 30%. “These factors have put significant pressure on profit margins for joint prosthesis manufacturers operating in France,” says Patrice Mertl.

France is recognised as a European leader in orthopaedic surgery innovation, with notable advances in surgical techniques and the development of new implants. However, in terms of the number of orthopaedic procedures performed, it does not rank among the leading European nations. For example, according to the French Open CCAM database, 328,000 hip and knee prostheses are implanted annually. Data from the Organisation for Economic Co-operation and Development (OECD) shows that the hip replacement procedure rate per 100,000 inhabitants places France 8th among OECD countries, behind Switzerland, Germany, Austria, Finland, Belgium, Norway, and the Netherlands. Furthermore, reimbursement rates in France remain below the European average, and well below those in the UK and Italy.

Systematic Price Reduction Imposed by French Government for 11 Years

The French Economic Committee for Health Products (CEPS), responsible for regulating healthcare product pricing, has consistently implemented price revisions since 2013. The European Association of Orthopaedic Implant Manufacturers, Importers, and Distributors (Afideo) and the French National Union of the Medical Technology Industry (SNITEM) have reported a 17% reduction in the price of total hip prostheses, an 11% drop for total knee prostheses, an 11% decline for shoulder implants, and a 10% decrease for spinal implants between 2013 and 2019. This year, the French government is once again seeking cost savings on orthopaedic prostheses as part of the proposed social security budget cuts.

The CEPS approach is systematic: when the average annual growth rate for certain categories of orthopaedic implants goes up, CEPS applies a price reduction in line with the increased demand. “However, this global rise in orthopaedic implant use is driven by an ageing population and advances in orthopaedic surgery, which has become safer and less invasive. Additionally, improvements in anaesthesia now mean surgery can be performed on older patients, including those aged 90 and over,” explains Patrice Mertl.

€231M in Savings Projected Over Three Years

CEPS adopts a different financial approach. In its latest annual report, it noted an 8% increase in sales volumes and a 9% rise in reimbursements by France's national health insurance (Assurance Maladie), totalling €917 million. Consequently, CEPS has forecast savings of €231 million over three years, starting in 2025, through a reduction in reimbursement rates for joint implants, with discounts ranging from 3.5% to 14% depending on the type of prosthesis.

This increased pricing pressure is already leading to the withdrawal of certain product lines from the French market, as manufacturers struggle with poor margins. “This particularly affects radial head prostheses, used to replace the radial head of the elbow, as well as certain long-term cemented implants used for complex fractures of long bones,” notes Patrice Mertl.

The French Society of Orthopaedic and Trauma Surgery (SOFCOT) warns of a potential reduction in the availability of prostheses and their associated apparatus in France. French hospitals and clinics are already experiencing difficulties replenishing stock, with some reporting supply shortages, especially in revision prostheses, which account for 15% of total orthopaedic procedures. International manufacturers are also reluctant to give priority to France, given the unattractive reimbursement rates.

Declining Appeal of the French Market

French orthopaedics, historically a driving force for innovation, is currently facing challenges in developing its own technologies for the domestic market, as evidenced by the example of dual mobility hip prostheses (see box 1). The tightening of the pricing environment, particularly restrictive, is weakening the fabric of small and medium-sized enterprises (SMEs) specialising in orthopaedics, which are increasingly being acquired by international groups. This includes Stryker’s acquisition of Wright Medical, following its merger with the French company Tornier.

Currently 60% of French companies in the orthopaedic implant sector have been acquired by foreign players, often accompanied by the offshoring of production. “The risks of greater dependence on imports in the French orthopaedic market are growing,” warns Patrice Mertl. There is also increasing competition from non-European manufacturers, particularly from China and India, who are seeking to enter the market with products where manufacturing quality is sometimes questionable.

Double Mobility: French Expertise at Risk

The concept of double mobility, developed in 1975 in Saint-Étienne by Professor Gilles Bousquet and engineer Jean-Pierre Boutin, features a dual articulation system which offers greater range of motion, reduced wear, and enhanced stability. This model, crucial for fragile patients, has significantly reduced the rate of post-operative dislocations.

With 100,000 procedures annually in France (30% of total hip replacements) and 600,000 worldwide, double mobility represents 10-15% of total hip replacement procedures. About ten med-tech companies supply this technology. However, the planned 12.5% reduction in reimbursement rates for these implants in 2025 (costing between €2,500 and €4,000) could place the sector in jeopardy. “"Our industrial partners will struggle to absorb this price shock, exposing the market to potential shortages,"” warns Patrice Mertl, Head of Orthopaedic Surgery at CHU Amiens and President of the Sofcot Congress.

Statement from the French Society of Orthopaedic Surgery Five Cost-Saving Measures

"Rather than significantly reducing the price of orthopaedic implants, which constitute just 15% of the total treatment costs in orthopaedic surgery – estimated at €12,000 for a hip replacement and €15,000 for a knee replacement – we propose five alternative measures,” explained Patrice Mertl, Head of the Department of Orthopaedic and Trauma Surgery at CHU Amiens, France, and President of the 2024 Congress of the French Society of Orthopaedic and Trauma Surgery (Sofcot).

  • Follow the 2007 HAS (French National Authority for Health) recommendations to limit the use of ceramic materials for patients over 65 years old (savings: €3.5 million).
  • Promote the use of cemented implants for patients over 80 years old.
  • Call for an enhanced recovery after surgery (ERAS) protocol (Fast-Track Surgery) after implant surgery.
  • Limit rehabilitation sessions to 15 for hip replacements and 25 for knee replacements.
  • Introduce a patient contribution of €10 per procedure (savings: €17 million).

“We do this all virtually on the computer, so we can make the osteotomy in multiple different places to decide where the most appropriate place to do the correction is.”

From here, relevant standard orthopaedic plates are selected for use in the surgery.

Following these preliminaries, surgical guides, jigs, and plastic models of the patient’s anatomy, in this first case the radius, are 3D printed and then sterilised for use in surgery.

“We make sure that the guide fits the bone in the patient exactly the way we planned for it to fit on the plastic bone. Once we have made sure that’s the case, we secure the guide to the bone with wires, and then we do whatever the plan has been,” says Lattanza.

In osteotomy, such plans generally involve drilling holes and then making the necessary bone cuts.

The great thing about this approach, Lattanza states, is that all that needs to be done to ensure the correction has been completed as planned during the surgery is to line up those holes.

She explains: “If the bone is rotated off 90° and when we drill those holes, they’re off 90° on the bone, we make the cut then we rotate and line up those holes to put the plate on because the plate holes are straight, and that’s how we know that we’ve got the correction.”

Beyond making relatively common osteotomies more accurate, a 3D provision also allows for more complex cases to be worked upon. Lattanza relays a recent case in which a child had broken the radius and ulna bones in their forearm.

“During the time that she was growing, this deformity got ‘very 3D’, meaning it was off in the sagittal, coronal, and axial plane,” says Lattanza.

“You can’t see the axial plane on an X-ray, and if you can’t see it, you can’t correct it.”  

In this case, the procedure required two cuts in the radius to restore it to normal anatomy, and one in the ulna.

“In my career prior to having the 3D technology, that’s something that is difficult or impossible to plan and to execute in the operating room, because you wouldn’t even be able to see that you needed two cuts to make it normal again,” explains Lattanza.

Lattanza is keen to add that the influence of 3D printing on preoperative planning and during surgery should not be a cause for complacency, particularly given that there remain limitations to 3D visualisations of CT scans, chiefly in that the current technology cannot show soft tissue.

“Some people think that this is kind of a phone it in now, but that’s not how it works,” she says.

“This is a collaboration between an engineer and a surgeon, and it has to be that way to get a good result.” 

Once we see where those changes are, we can plan where we’re going to cut the bone.

Dr Lattanza

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Caption. Credit: 

Phillip Day. Credit: Scotgold Resources

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